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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00830388
Other study ID # F080520002
Secondary ID
Status Completed
Phase Phase 4
First received January 23, 2009
Last updated August 21, 2012
Start date November 2008
Est. completion date September 2010

Study information

Verified date July 2012
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive Potassium Hydroxide (KOH) using calcofluor. Ketoconazole 2% foam will be used to determine its effectiveness, safety and satisfaction when used to treat tinea versicolor.


Description:

Objectives

1. To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor

2. To assess the safety of ketoconazole 2% foam for the treatment of tinea versicolor based on the occurrence of adverse events.

3. To assess treatment satisfaction as rated by patients

Study Design:

This will be a mono-centered, single arm, open-label pilot study. Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive KOH using calcofluor, will be enrolled at the University of Alabama at Birmingham. There will be 4 scheduled visits (baseline, week 1, week 2, and week 4). A target area will be identified and mycological and clinical assessments will be performed at this site as well as a global assessment of each subject. Ketoconazole 2% foam will be applied to all affected areas for 2 weeks with a follow-up visit at week 4. Skin scraping using a disposable #15 blade for calcofluor/potassium hydroxide (KOH) assessment and photographs of target lesions will be performed at baseline, week 1, week 2, and week 4. Photographs will be taken at baseline and at week 4 (only if KOH is positive). Body surface area estimation of disease will also be performed at each visit. Evaluation of scale, hyperpigmentation/erythema, and hypopigmentation using a 4 point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) of the target area will be performed at baseline, week 1, week 2, and week 4. A global assessment will be conducted at each visit using the same 4 point scale. Patient questionnaires will be administered at baseline and week 2 to assess symptoms and satisfaction with study medication.


Recruitment information / eligibility

Status Completed
Enrollment 11
Est. completion date September 2010
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

1. Male or female patients, aged 19 years and over.

2. Clinical presentation of tinea versicolor.

3. Positive KOH using calcofluor.

4. The ability to provide informed consent (including photography release)

Exclusion Criteria:

1. Use of topical antifungal to the affected area in the past 30 days

2. Use of topical steroid to the affected area in the past 14 days

3. If female, positive urine pregnancy test at screening (female patients of childbearing potential must be practicing a reliable method of birth control, not be planning a pregnancy, not be breast-feeding during the study)

4. Patients with a dermatologic condition in the region of the treatment site that in the investigator's opinion may interfere with the study results

5. Current diagnosis of immunocompromising conditions

6. Any medical or psychiatric condition that may interfere with treatment or compliance

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Ketoconazole 2% Foam
Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks.

Locations

Country Name City State
United States UAB Dermatology Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
Boni Elewski, MD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Effect of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Eleven participants were tested for the microscopic presence of yeast. At four weeks, all participants were re-tested and deemed positive if yeast continued to be present microscopically. 4 weeks No
Secondary To Assess the Safety of Ketoconazole 2% Foam for the Treatment of Tinea Versicolor Based on the Occurrence of Adverse Events. Adverse events were used to assess safety. 4 weeks Yes
See also
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Not yet recruiting NCT05730244 - A Study of the Clinical Efficacy and Safety of 100% Cassia Alata Extract Against Tinea Versicolor Phase 1
Completed NCT04110834 - Clinical Assessment of Itraconazole Self Nano Emulsifying Drug Delivery System Intermediate Gel Phase 2
Completed NCT04110860 - Clinical Assessment of Voriconazole Self Nano Emulsifying Drug Delivery System Intermediate Gel Phase 2
Completed NCT06305637 - A Study Comparing Ketoconazole Shampoo, 2% and Ketoconazole 2% Shampoo (RS) in the Treatment of Tinea Versicolor. Phase 1